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写药理综述,给个题目建议下,谢了 [复制链接]

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离线guodong
 
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只看楼主 倒序阅读 使用道具 0楼 发表于: 2006-10-18
— 本帖被 piaopengqq 从 :: 基础课程 :: 移动到本区(2009-04-21) —
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离线merck
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只看该作者 1楼 发表于: 2006-10-18
写Vectibix(panitumumab,帕尼单抗)的研究进展就行了,刚刚通过FDA的。估计不久会在中国上市。

FDA Approves Amgen Colon Cancer Drug Vectibix
Main Category: GastroIntestinal / Gastroentorology News
Article Date: 02 Oct 2006 - 0:00am (PDT)




The U.S. Food and Drug Administration said on Wednesday it had approved Amgen Inc's drug Vectibix for the treatment of advanced colon cancer.

Vectibix, known chemically as panitumumab, was approved for use in patients whose colon cancer has spread after chemotherapy has failed.

The drug, which is expected to compete with Erbitux from ImClone Systems Inc. has been considered one of the most important experimental medicines in Amgen's drug pipeline. Analysts have projected that eventual peak sales for the drug would exceed $1 billion a year.

Vectibix, a monoclonal antibody that binds to a protein called epidermal growth factor receptor on some cancer cells, received an accelerated approval after showing effectiveness in slowing tumor growth and, in some cases, reducing the size of the tumor, the FDA said in a statement.

In the United States, it is estimated that 150,000 new cases of colon cancer will be diagnosed and 55,000 deaths will occur from colon and rectal cancer in 2006.

"This approval adds a treatment option for patients with an advanced stage of a disease that can be life-threatening," said Dr. Steven Galson, director of FDA's Center for Drug Evaluation and Research.

A pivotal-stage trial showed that patients treated with Vectibix showed a better-than-expected 46 percent decrease in the rate of tumor growth versus those who received supportive care.

As part of the approval, Amgen committed to conduct a post marketing trial to show whether the drug improves patients' survival in patients with fewer prior chemotherapies, the FDA said.

Amgen, the world's largest biotechnology company, gained full rights to the drug through its acquisition of Abgenix.

UCLA Jonsson Cancer Center researcher Dr. J. Randolph Hecht, a gastroenterologist, was the national principal investigator for studies of this drug.

UCLA's Jonsson Cancer Center
http://www.cancer.mednet.ucla.edu

http://www.amgen.com
Information on Vectibix
[ 此贴被merck在2006-10-18 17:31重新编辑 ]
离线guodong
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只看该作者 2楼 发表于: 2006-10-20
厉害,太厉害
太新,没什么参考质料啊
要点普通的啊
离线merck
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只看该作者 3楼 发表于: 2006-10-20
引用第2楼guodong2006-10-20 21:21发表的“”:厉害,太厉害太新,没什么参考质料啊要点普通的啊

普通的找个英文的改写成中文的就行了。
太新写的才有意思。要知道,很快可能进入中国市场的药,上市过不了多久,这种药的综述多的就和牛毛一样。
离线guodong
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只看该作者 4楼 发表于: 2006-10-20
好,多谢
离线merck
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只看该作者 5楼 发表于: 2006-10-20
再提供一个。

美FDA批准达沙替尼治白血病
2006年6月29日,美国食品药品管理局(FDA)经加快程序批准了美国百时美施贵宝公司开发的抗肿瘤新药达沙替尼(Dasatinib/Sprycel),用于已经治疗,包括甲磺酸伊马替尼(Imatinib mesylate/Gleevec)耐药或不能耐受的慢性骨髓性白血病所有病期(慢性期、加速期、淋巴系细胞急变期和髓细胞急变期)的成人患者。同时,FDA也经正常程序批准达沙替尼治疗对其他疗法耐药或不能耐受的费城染色体阳性的急性成淋巴细胞性白血病成人患者。

  6月21日,百时美施贵宝在欧洲血液病协会年会上报告了其新药Sprycel治疗白血病的进展。结果显示,Sprycel可有效治疗部分对一线化疗药——诺华的格列卫(Glevec,伊马替尼)抗药的慢性粒细胞白血病(CML)和急性淋巴细胞白血病(ALL)患者。
  百时美施贵宝提交结果的临床试验共有4项,患者均按70mg一日二次的剂量口服Sprycel。在名为START-A的临床试验中,192名伊马替尼抗药的加速期CML患者服用Sprycel后,分别有59%和34%的人获得了血液学和细胞遗传学上的疗效;START-B试验中,109名出现髓系原始细胞危象(myloid blast crisis)的伊马替尼抗药患者中,有49%和44%分别获得了血液学和细胞遗传学疗效;另外两项研究显示,在伊马替尼抗药或不能耐受的慢性期CML患者中,有90%和51%获得血液学和细胞遗传学疗效;此二疗效在Ph染色体阳性的ALL患者中出现的比率为49%和22%。
  Sprycel在试验中显示出较好的耐受性。不良反应包括3~4级的血小板减少和中性粒细胞减少;此外,腹泻、皮疹、头痛、浅表水肿、胸膜腔积液和肝酶升高可见于部分病例。
  Sprycel是一种Bcr-Abl酪氨酸蛋白激酶的抑制剂。除T315IABL变异外,它对该激酶的其他变异均有抑制作用,其抑制强度较伊马替尼高300倍以上,因此在疗效和有效谱方面均优于伊马替尼。据估计,Sprycel在上市后,CML和ALL患者中30%伊马替尼化疗无效者将是它的主要市场,年销售潜力将在5亿美元以上。然而,有临床报道显示,伊马替尼提高剂量后可增加有效率。这一信息给Sprycel的临床价值和市场前景或多或少的带来了负面影响。


http://www.bloodjournal.org/cgi/content/full/108/1/28?ijkey=c50344767a9d994e9ed75be5e2b60d1e2880d401
[ 此贴被merck在2006-10-20 21:51重新编辑 ]
离线guodong
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只看该作者 6楼 发表于: 2006-10-21
多谢了
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